Quality Director for Pharmacovigilance and Lifecycle Management
1 month ago
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.
We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Salary RangeThe estimated salary for this position is around £110,000 - £140,000 per annum, based on industry standards and location.
About the RoleThis is an exciting opportunity to lead key activities in pharmacovigilance and lifecycle management, ensuring regulatory compliance and patient safety.
The Senior Director, Quality Business Partner, Pharmacovigilance and Regulatory is responsible for developing and delivering the quality strategy for pharmacovigilance and lifecycle management activities.
Key Responsibilities:- Develop and deliver quality strategies in pharmacovigilance and lifecycle management, ensuring regulatory compliance and patient safety.
- Manage a small team of quality business partners and provide assurance to GSK R&D senior management that GSK processes for managing safety data are effective.
- Continually evaluate the strategic approach and drive changes in R&D QuRE processes to meet the changing needs of the organization, regulatory requirements and industry best practices.
- Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis.
- Provide input into the global audit plan based on identified signals/trends/risks/gaps.
- Guide the business to build in quality by design and enable the execution of external regulations and internal standards.
- Bachelor's degree or equivalent in scientific or quality-related field.
- Experience in drug development, pharmacovigilance operations, regulatory compliance or quality management.
- Experience in clinical, medical, pharmacovigilance or regulatory quality.
- Must have operated in a senior management role with extensive supervisory/management experience.
- Knowledge of GCP, pharmacovigilance/drug safety and regulatory requirements.
- Experience leading global multidisciplinary, functional, line and matrix teams.
- Experience managing key stakeholders.
We offer a dynamic and inclusive work environment where you can thrive and grow your career.
As an equal opportunities employer, we welcome applications from diverse candidates and are committed to creating an inclusive workplace culture.
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